Mounting arrangement and coupling assembly for a drug-delivery device

ABSTRACT

A mounting arrangement for a drug-delivery device is proposed, the mounting arrangement comprising: a plug element with a longitudinal axis (L) and a housing part having a recess with a side wall which is adapted to receive the plug element. At least one of the plug element or the side wall of the recess are provided with a protrusion for fixing the plug element in a given position relative to the housing part by a force-fit engagement. Furthermore, a coupling assembly is proposed, the coupling assembly comprising the plug element and the housing part being mechanically coupled to each other.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/172,331, filed Jun. 3, 2016, which is a continuation of U.S.patent application Ser. No. 13/258,161, filed Dec. 6, 2011, now U.S.Pat. No. 9,364,613, which is a U.S. National Phase Application pursuantto 35 U.S.C. §371 of International Application No. PCT/EP2010/054344filed Mar. 31, 2011, which claims priority to European PatentApplication No. 09004667.3 filed on Mar. 31, 2009 and U.S. ProvisionalPatent Application No. 61/169,861 filed Apr. 16, 2009. The entiredisclosure contents of these applications are herewith incorporated byreference into the present application.

FIELD OF INVENTION

The present disclosure relates to a mounting arrangement and a couplingassembly with a housing part and a plug element suitable for use in adrug-delivery device. The drug-delivery device is preferably designed asa pen-type injector by which a number of predetermined or user-settabledoses of a medical or pharmaceutical product can be administered. Inparticular, the present disclosure relates to a drug-delivery devicewhich can be used by a person without formal medical training, e.g.advanced medical education.

BACKGROUND

Drug-delivery devices are in widespread use. For example, they can beapplied by persons who do not have a formal medical background. Medicaldevices can be used to administer accurate and predefined doses of amedical product such as heparin or insulin. In particular, such devicescan be used for a healthcare therapy whenever there is demand for amedical or pharmaceutical product being administered on a regular or anirregular basis over a short term or a long term period.

These circumstances set a number of requirements for the drug-deliverydevice of this kind which should be met. The device should be robust inconstruction, yet easy to use in terms of the manipulations of theparts, easily to be understood by the operator concerning the handling,and/or be suitable for an accurate delivery of the required dose of themedical or pharmaceutical product. Dose setting should be easy andunambiguous. In cases when the device is to be disposable rather thanreusable, the device should be cheap to manufacture and easy to disposeof.

SUMMARY

The object of the invention is to provide a mounting device and acoupling assembly which are reliable and cheap to manufacture. Theobject is obtained by the features of the independent claims.Advantageous embodiments are disclosed in the sub claims.

According to a first aspect, a mounting arrangement for a drug-deliverydevice is provided. The mounting arrangement may comprise a plugelement. The plug element may comprise a longitudinal axis. The mountingarrangement may comprise a housing part. The housing part may have arecess with a side wall which is adapted to receive the plug element. Atleast one of the plug element and the side wall of the recess may beprovided with a protrusion. The protrusion may be adapted and arrangedfor releasably or permanently fixing the plug element in a givenposition relative to the housing part by a force-fit engagement.

This may enable a cheap manufacturing of the housing part and the plugelement. Furthermore, by plugging the plug element into the recess ofthe housing part, a very reliable mechanical coupling may beestablished. In particular, the mechanical coupling may be suitable foruse in a drug-delivery device requiring high precision with smalltolerances for tiny mechanical components.

In a preferred embodiment, the longitudinal profile of the protrusion isinclined along a longitudinal end section of the protrusion for thepurpose of facilitating the insertion of the plug element into therecess when establishing the force-fit engagement. This enables toreduce mechanical stress being exerted on the protrusion and the plugelement and such may facilitate an accurate adjusting of the plugelement relative to the housing part.

According to a further preferred embodiment, the longitudinal profile ofthe protrusion is inclined along the longitudinal end section such thatthe inclination is monotonous.

According to a further preferred embodiment, the inclination of thelongitudinal profile is constant.

According to a further preferred embodiment, the longitudinal profile ofthe protrusion is arranged and designed such that the longitudinal anglebetween the longitudinal end section and the longitudinal axis isbetween 1° and 30°.

According to a further preferred embodiment, the longitudinal profile ofthe protrusion is designed such that it comprises the shape of a convexcurve. This enables an easy plugging of the plug element into the recessof the housing part and increases a mechanical stability of theprotrusion.

According to a further preferred embodiment, a longitudinal section ofthe protrusion is arranged adjacent to the longitudinal end section andhas a constant radial distance relative to the longitudinal axis. Thisenables to increase a friction force of the force-fit engagement byincreasing a contact surface between the protrusion and the plug elementor the side wall of the recess and thus a reliable mechanical coupling.

According to a further preferred embodiment, a cross-section of theprotrusion perpendicular to the longitudinal axis is designed such thatthe radial distance between the protrusion and the longitudinal axisdecreases monotonously to a given minimum on a first side face. On asecond side face which is adjacent to the first side face, the radialdistance increases monotonously.

According to a further preferred embodiment, the cross-section isdesigned such that it has a triangular shape. This allows an easymanufacturing process of the protrusion. For example, the protrusion maybe manufactured in a molding process.

According to a further preferred embodiment, the first side face and thesecond side face are arranged in an azimuth direction angle of about 60°relative to each other. This enables a high mechanical stability of theprotrusion which still enables an easy and accurate mechanical coupling.A first edge between the first side face and the second side face mayfacilitate a guiding and fixing of the plug element into a predeterminedposition relative to the housing. In particular, the first edge mayfacilitate to guide and fix the plug element in a position such that thelongitudinal axis of the plug element may be arranged congruently inregard to a longitudinal axis of the recess.

According to a second aspect, a coupling assembly for a drug-deliverydevice is provided. The coupling assembly may comprise a housing parthaving a recess with a side wall. The coupling assembly may furthercomprise a plug element with a longitudinal axis being arranged in therecess of the housing part at least partially. At least one of the plugelement and the side wall of the recess may have a protrusion. Theprotrusion may be arranged at least partially in the recess of thehousing part between the side wall of the recess and the plug element.The protrusion may be deformed in order to fix the plug element in agiven position relative to the housing part in a force-fit engagement.

This may enable a very reliable mechanical coupling which may inparticular be suitable for use in a drug-delivery device.

According to a further preferred embodiment, the coupling assemblycomprises a plurality of protrusions. This enables a high mechanicalstability by increasing friction forces with an increasing number ofprotrusions. This may further enable an accurate adjusting of the plugelement relative to the housing part such that the plurality ofprotrusions facilitates a guidance of the plug element into apredetermined position relative to the housing part.

According to a further preferred embodiment, the plurality ofprotrusions is arranged such that any further axis running perpendicularto the longitudinal axis crosses at most one of the protrusions. Thisenables a reliable coupling assembly such that mechanical stress beingexerted on the plug element and on the protrusions may be reduced. Aprecision of the adjustment may thus further be increased.

According to an embodiment, a drug-delivery device is provided. Thedevice may comprise the previously described coupling assembly.

Preferably, at least two members of the drug-delivery device, e.g. ahousing and a housing insert of the device, may be, releasably orpermanently, coupled by means of the coupling assembly. The at least twomembers may be secured against translational and/or rotational movementwith respect to each other by means of the coupling assembly.

According to an embodiment, the drug-delivery device is a pen-typedevice.

A pen-type device may comprise at least one, preferably two or moresleeves. These sleeves may be especially suited for being connected bymeans of the coupling assembly due to their essentially rotationallysymmetrical shape.

According to a preferred embodiment, a mounting arrangement for adrug-delivery device comprises a plug element with a longitudinal axisand a housing part having a recess with a side wall which is adapted toreceive the plug element, wherein at least one of the plug element andthe side wall of the recess are provided with a protrusion for fixingthe plug element in a given position relative to the housing part by aforce-fit engagement.

According to a preferred embodiment, a coupling assembly for adrug-delivery device comprises

-   -   a housing part having a recess with a side wall,    -   a plug element with a longitudinal axis being arranged in the        recess of the housing part at least partially,    -   wherein at least one of the plug element and the side wall of        the recess have a protrusion being arranged at least partially        in the recess of the housing part between the side wall of the        recess and the plug element and being deformed in order to fix        the plug element in a given position relative to the housing        part in a force-fit engagement.

BRIEF DESCRIPTION OF THE FIGURES

Further features and refinements become apparent from the followingdescription of the exemplary embodiments in connection with theaccompanying figures. The figures illustrate:

FIG. 1 is a mounting device comprising a plug element and a housing partwith a recess,

FIG. 2 is the mounting device with the housing part having protrusions,

FIGS. 3A, B, C and D are a first embodiment of the protrusion,

FIGS. 4A and B are a second embodiment of the protrusion,

FIG. 5 is a third embodiment of the protrusion,

FIG. 6 is a longitudinal profile of the third embodiment,

FIG. 7 is an arrangement of the protrusions, and

FIG. 8 is an exemplary embodiment of a drug-delivery device.

Elements of the same design or function are referenced by the samereference numerals in the figures.

DETAILED DESCRIPTION

FIG. 1 shows a mounting arrangement comprising a plug element 2 with afront surface 3 and a lateral surface 4. The plug element 2 furthercomprises a longitudinal axis L. A circumferential first chamfer 6 isarranged between the front surface 3 and the lateral surface 4. Themounting arrangement further comprises a housing part 8 having a recess10 with an opening 11 and a side wall 12. A circumferential secondchamfer 14 is arranged between the side wall 12 of the recess 10 and anupper side 15 of the housing part 8. In a preferred embodiment, thefront surface 3 of the plug element 2 has the shape of a cylinder andthe recess 10 of the housing part 8 has the shape of a hollow cylinder.The housing part 8 may be a sleeve, for example. Alternatively, the plugelement 2 may be a sleeve (not explicitly shown), e.g. a hollowcylinder. Preferably, the diameter of the plug element 2 being shown inFIG. 1 is smaller than the diameter of the recess 10 in FIG. 1. Theouter diameter of the plug element 2 is expediently smaller than theinner diameter of the recess 10 of the housing part 8.

FIG. 2 shows the mounting arrangement with the plug element 2 and thehousing part 8. Three protrusions 16 are arranged on the side wall 12 ofthe recess 10. The protrusions 16 may also be arranged on the lateralsurface 4 of the plug element 2. It is also possible that theprotrusions 16 are arranged on the side wall 12 of the recess 10 as wellas on the lateral surface 4 of the plug element 2. There may, forexample, also be arranged five protrusions 16 on the side wall 12 of therecess. It is also possible that a different number of the protrusions16 is arranged on the side wall 12 and/or the lateral surface 4. In thefollowing, it will only be referred to the protrusion 16 in singularknowing that there may be a plurality of protrusions 16.

The mounting assembly is designed such that the plug element 2 and thehousing part 8 can be mechanically coupled for establishing a couplingassembly. The coupling assembly can be such that the recess 10 receivesthe plug element 2 at least partially in order to fix it in a givenposition relative to the housing part 8. In particular, the plug element2 can be arranged in the recess 10 such that its longitudinal axis L isin parallel to a longitudinal axis of the recess 10. The plug element 2may for example be press fitted into the recess 10 of the housing part8. The protrusions 16 may take up slack or play between plug element 2and housing part 8, which may arise, for example, by the plug element 2having an outer diameter which is less than the inner diameter of therecess of the housing part 8, if the protrusions 16 are disregarded. Aminimal distance between two protrusions 16, which may face each other,is expediently less than the outer diameter of the plug element 2.

The housing part 8 and the plug element 2 are preferably parts for adrug deliver device. A sleeve for the plug element has the advantagethat an element of the drive mechanism, such as the piston rod, may bemoved through the housing part and the plug element during operation ofthe device.

The coupling assembly is designed to fix the plug element 2 in the givenposition relative to the housing part 8 by a force-fit engagement. Theforce-fit engagement is established between the protrusion 16 beingarranged between the lateral surface 4 of the plug element 2 and theside wall 12 of the recess. In the case that the protrusion 16 isarranged on the lateral surface 4 of the plug element 2, the force-fitengagement is established between the protrusion 16 and the housing part8 at the side wall 12 of the recess 8. In a preferred embodimenthowever, the protrusion 16 is arranged on the side wall 12 as shown inFIG. 2. In this case, the force-fit engagement is established betweenthe protrusion and the plug element 2.

The plug element 2 and the recess 10 are designed such that with atleast one protrusion 16 being arranged on the lateral surface 4 and/orthe side wall 12, the protrusion 16 and/or the plug element 2 isdeformed during the assembly when the plug element 2 is plugged into therecess 10. In a preferred embodiment, in the case that the protrusion 16is arranged on the lateral surface 4 of the plug element 2, when theplug element 2 is plugged into the recess 10, the protrusion 16 and theplug element 2 are deformed and establish the force-fit engagement. In afurther embodiment, the plug element 2 is made of a material having asmaller hardness in comparison to a hardness of the protrusion 16 suchthat the deformation rather concerns the plug element 2. The plugelement 2 may be, for example, made of plastic. The mounting assembly isdesigned such that the housing part 8, except for the protrusion 16, iseffectively prevented from being deformed. In particular, the housingpart 8 can effectively be prevented from breaking.

If the protrusion 16 is arranged on the side wall 12 of the recess 10 asshown in FIG. 2, the force-fit engagement is established between theprotrusions 16 and the plug element 2. However, it may also be possiblethat one or more protrusions 16 are arranged on the lateral surface 4 ofthe plug element 2. In this case, a force-fit engagement is establishedbetween the protrusion 16 and the side wall 12 of the housing part 8.There may, for example, protrusions 16 be arranged on the lateralsurface 4 of the plug element 2 and on the side wall 12 of the housingpart 8.

The protrusion 16 is arranged and designed such that its longitudinalprofile in regard to the longitudinal axis L inclines along alongitudinal section 18. This may facilitate the insertion of the plugelement 2 into the recess 10 during a manufacturing of the couplingassembly.

The protrusion 16 may, for example, be made in a molding process whichis also known as die-casting. This may enable to manufacture theprotrusion 16 integrally with the plug element 2 or the housing part 8,depending on where it shall be arranged. The protrusion 16 may also bemade in a different process. In a preferred embodiment, a plurality ofprotrusions 16 is arranged on the side wall 12 of the recess 10 and/oron the lateral surface 4 of the plug element 2. In a further preferredembodiment, the plurality of protrusions 16 is arranged such that anyfurther axis running perpendicular to the longitudinal axis L crosses atmost one of the protrusions 16. This enables a reliable coupling suchthat a friction force can be increased in order to strengthen theforce-fit engagement. The deformation of the protrusion 16 and/or theplug element 2 may be plastically and/or elastically.

FIGS. 3A to 3D show a first embodiment of the protrusion 16. In theFIGS. 3A to 3D the protrusion 16 is arranged on the side wall 12 of therecess 10. However, the protrusion 16 may also be arranged on thelateral surface 4 of the plug element 2. FIG. 3A shows the firstembodiment of the protrusion 16 in a front view. In the firstembodiment, the protrusion 16 comprises a longitudinal end section 18having a first side face 20 and a second side face 22, the first sideface 20 and the second side face 22 being separated from each other by afirst edge 24. In a longitudinal direction, the first edge 24 isarranged between a first corner 26 and a free corner 28. In the casewhen the protrusion 16 is arranged on the lateral surface 4 of the plugelement 2, the first axial end 26 of the protrusion 16 is arranged inthe direction towards the front surface 3 of the plug element 2. In thecase when the protrusion 16 is arranged on the side wall 12 of therecess 10, the first axial end 26 of the protrusion is arranged in thedirection towards the opening 11 of the recess 10.

FIG. 3B shows the longitudinal profile of the protrusion 16 in regard tothe longitudinal axis L. A radial distance R between the side wall 12 ofthe recess 10 and the free corner 28 can also be named as the radius ofthe protrusion 16. In a preferred embodiment, the protrusion 16 isdesigned such that the radial distance R increases with an increasingdistance to the first axial end 26. The radial distance R of theprotrusion may be, for example, 0.25 Millimeter. In other words, thelongitudinal profile of the protrusion 16 inclines along thelongitudinal end section 18. In a further preferred embodiment thelongitudinal profile of the longitudinal end section 18 is designed suchthat the radial distance R increases at a constant rate with anincreasing distance to the first axial end 26, as it is shown in theFIGS. 3B and 3D. In other words, the longitudinal profile of thelongitudinal end section 18 is designed such that its inclination isconstant. In a preferred embodiment, the longitudinal profile of theprotrusion 16 is arranged and designed such that a longitudinal angle A1between the longitudinal end section 18 and the longitudinal axis L isbetween 1° and 30°.

FIG. 3C shows the first embodiment of the protrusion 16 from an aboveview. The free edge 24 being arranged between the first axial end 26 andthe free corner 28 can serve for guiding the plug element 2 relative tothe housing part 8 during the mechanical assembly of the plug element 2and the housing part 8. During the assembly, the first edge 24 may becut into the plug element 16. As such, the first edge 24 may be designedas a cutting-edge.

FIG. 3D shows the first embodiment of the protrusion 16 in a perspectiveview. An azimuth direction angle A2 between the first side face 20 andthe second side face 22 may for example be between 15° and 90°. In apreferred embodiment, the azimuth direction angle A2 between the firstside face 20 and the second side face 22 is about 60°. This enables areliable coupling assembly such that on the one hand the azimuthdirection angle A2 enables a high mechanical stability of the protrusion16 preventing breakage and on the other hand, it is thin enough forenabling a deformation of the plug element 2 when being plugged into therecess 10.

FIGS. 4A and 4B show a second embodiment of the protrusion 16. FIG. 4Ashows the longitudinal profile of the protrusion 16. In a preferredembodiment, the free edge 24 between the first axial end 26 and the freecorner 28 comprises a convex bending. The free edge 24 between the firstaxial end 26 and the free corner 28 may, for example, comprise a firstpart with a convex bending and second part being designed in parallel tothe longitudinal axis L.

FIG. 4B shows the second embodiment of the protrusion 16 in aperspective view. In FIG. 4B the convex bending extends over the lengthof the free edge 24.

FIGS. 5 and 6 show a third embodiment of the protrusion 16 from aperspective view and in the longitudinal profile respectively. The thirdembodiment of the protrusion 16 as shown in the FIGS. 5 and 6 comprisesthe longitudinal end section 18 as shown in FIGS. 3A to 3D and alongitudinal section 30 being arranged on an opposite side relative tothe first axial end 26 of the longitudinal end section 18. However, thethird embodiment of the protrusion 16 may also comprise the longitudinalend section 18 as shown in the FIG. 4A or 4B and the longitudinalsection 18.

In a preferred embodiment, the radial distance R of the longitudinalsection 30 is constant. This enables a reliable coupling assembly suchthat the friction of the force-fit engagement between the protrusion 16and the housing part 8 or the lateral surface 4 of the plug element 2respectively can be increased. The cross-section 32 of the longitudinalsection 30 may be, for example, shaped as a triangle. The cross-section32 of the longitudinal section 30 may also be shaped differently. In apreferred embodiment, the cross-section 32 of the protrusion 16 isdesigned such that in a direction perpendicular to the longitudinal axisL the radial distance R decreases monotonously to a given minimum andafterwards increases monotonously.

FIG. 6 shows the longitudinal profile of the third embodiment of theprotrusion 16 comprising the longitudinal end section 18 and thelongitudinal section 30.

FIG. 7 shows two protrusions 16 being arranged on the lateral surfacesuch that the first side face 20 of a left-hand protrusion 16 a is incontact with the second side face 22 of a right-hand protrusion 16 b.

In FIG. 8 an exemplary embodiment of a drug-delivery device 40 is shown.The drug-delivery device 40 comprises a housing 41. The housing 41comprises a tubular shape. The housing 41 may comprise or may beembodied as a sleeve. The housing 41 is configured to house members ofthe drug-delivery device 40, e.g. a guide member, a drive member and/ora dosing member (not explicitly shown). Preferably, these members maycomprise or may be embodied as a sleeve, respectively. Accordingly,these members may be rotationally symmetric. The drug-delivery device 40comprises a cartridge holder 42. The cartridge holder 42 is connectable,preferably releasably connectable, to the housing 41 of the device 40.

The drug-delivery device 40 may be an injection device. The device 40may be a pen-type device, in particular a pen-type injector.

The device 40 comprises the previously described coupling assembly (notexplicitly shown). The coupling assembly may be adapted and arranged forproviding a reliable mechanical coupling between members of the device40. Especially a pen-type device may comprise a plurality of sleeves.These sleeves may be especially suited for being coupled to each otherby means of the coupling assembly due to their generally rotationallysymmetric basic shape.

In particular, at least two members of the device 40, e.g. the housing41 and the guide sleeve, may be permanently or releasably coupled bymeans of the coupling assembly. In particular, axial and/or rotationalmovement of these members of the device 40 may be prevented by means ofthe coupling assembly.

The device 40 comprises a cartridge 43. The cartridge 43 is retained inthe cartridge holder 42. The cartridge holder 42 stabilizes thecartridge 43 mechanically. The cartridge 43 may hold a plurality ofdoses of a drug.

The term “drug”, as used herein, preferably means a pharmaceuticalformulation containing at least one pharmaceutically active compound,wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, anantibody, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound.

In a further embodiment the pharmaceutically active compound is usefulfor the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis.

In a further embodiment the pharmaceutically active compound comprisesat least one peptide for the treatment and/or prophylaxis of diabetesmellitus or complications associated with diabetes mellitus such asdiabetic retinopathy.

In a further embodiment the pharmaceutically active compound comprisesat least one human insulin or a human insulin analogue or derivative,glucagon-like peptide (GLP-1) or an analogue or derivative thereof, orexedin-3 or exedin-4 or an analogue or derivative of exedin-3 orexedin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

-   H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   wherein the group -Lys6-NH2 may be bound to the C-terminus of the    Exendin-4 derivative; or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,

-   des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,-   des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,-   H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]    Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(S1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2;    or a pharmaceutically acceptable salt or solvate of any one of the    afore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

The invention claimed is:
 1. A pen-type drug injection devicecomprising: a housing having a longitudinal axis and a recess with aside wall comprising at least two protrusions circumferentially spacedapart from each other and extending longitudinally, where eachprotrusion is deformable from a non-deformed shape to a deformed shape,where the non-deformed shape has longitudinal profile defined by aradial distance (R) measured relative to the side wall and perpendicularto the longitudinal axis; and a plug, wherein the plug is mechanicallycoupled within the recess by a force fit contact with a section of thelongitudinal profile of the non-deformed shape to transform eachprotrusion to the deformed shape such that R is decreased in the sectionof the longitudinal profile that is in the force fit contact with theplug, where a friction force is caused by a deformation of theprotrusion when the plug is coupled to the housing.
 2. The device ofclaim 1 wherein the longitudinal profile of each protrusion has aconstant radial distance (R).
 3. The device of claim 1 wherein thehousing is designed not to deform when the protrusion is deformed. 4.The device of claim 1 wherein the recess has an inner diameter greaterthan an outer diameter of the plug defining a play distance that istaken up by each protrusion.
 5. The device of claim 1 wherein the plugis a sleeve.
 6. The device of claim 5 wherein the sleeve is a cartridgeconfigured to hold a drug.
 7. The device of claim 6 wherein the drugcomprises a pharmaceutical formulation containing at least onepharmaceutically active compound, wherein the pharmaceutically activecompound has a molecular weight up to 1500 Da and/or is a peptide, aprotein, a polysaccharide, a vaccine, a DNA, an RNA, an enzyme, anantibody, a hormone or an oligonucleotide.
 8. The device of claim 6wherein the drug comprises at least one peptide for the treatment and/orprophylaxis of diabetes mellitus or complications associated withdiabetes.
 9. The device of claim 6 wherein the drug comprises at leastone human insulin or a human insulin analogue or derivative,glucagon-like peptide (GLP-1) or an analogue or derivative thereof, orexedin-3 or exedin-4 or an analogue or derivative of exedin-3 orexedin-4.
 10. The device of claim 6, further comprising a cartridgeholder configured to retain the cartridge.
 11. The device of claim 5wherein the sleeve is a cartridge holder configured to retain acartridge configured to hold a drug.
 12. The device of claim 1, whereinthe plug comprises one or more deformable protrusion.
 13. The device ofclaim 12, wherein the housing protrusions or the one or more plugdeformable protrusion deforms plastically.
 14. The device of claim 12,wherein the housing protrusions or the one or more plug deformableprotrusion deforms elastically.
 15. The device of claim 1, wherein aradial cross section of at least one of the protrusions changes alongthe longitudinal axis of the housing.
 16. The device of claim 1, whereinthe housing and the plug are rotationally symmetric.